TETRIS II 4° T24061124

GUDID 04047844011065

The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is aviable in a variety of sizes and angulations thereby enabling the surgeon to choose the size best uited to the individual pathology and anatomical condition.

SIGNUS Medizintechnik GmbH

Metallic spinal interbody fusion cage
Primary Device ID04047844011065
NIH Device Record Keydf0370a3-1f78-4ffc-a5ca-40c23368b6e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTETRIS II 4°
Version Model NumberLumbar cage, angled
Catalog NumberT24061124
Company DUNS344203948
Company NameSIGNUS Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49602391660
Emailinfo@signus.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844011065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number8
Public Version Date2020-02-24
Device Publish Date2015-09-24

On-Brand Devices [TETRIS II 4°]

04047844011133The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011102The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011089The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011065The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011041The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844011010The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010983The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010952The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010921The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010877The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010846The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010815The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010785The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010754The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010723The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010693The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010662The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
04047844010631The basic shape of the TETRIS II devices is a hollow structual frame having a rounded, tapered l
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